BOND: Direct Breastfeeding to Enhance Maternal and Infant Health in Congenital Heart Disease
1 other identifier
interventional
266
1 country
17
Brief Summary
The primary objective of this study is to enhance the rates of direct breast feeding (DBF) among infants with congenital heart disease (CHD), and to gain insights into the implications of DBF on key metrics of child and parent well-being. A multicenter parallel cluster platform design will be employed. The intervention will be a multifaceted approach to enhance direct breastfeeding. Participating sites will be randomized into either intervention (strategies to enhance direct breastfeeding) or conventional care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2026
CompletedFirst Posted
Study publicly available on registry
May 13, 2026
CompletedStudy Start
First participant enrolled
July 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
September 10, 2026
September 1, 2026
2.9 years
April 29, 2026
September 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
direct breastfeeding at 4 months
any direct breastfeeding (yes/no)
4 months
Secondary Outcomes (8)
direct breastfeeding at 4 months in subpopulation of African Americans
4 months
Difference in Parental Stress Scale™ (PSS) from baseline to 4 months
baseline to 4 months
Difference in Mother-Infant Bonding Scale (MIBS) from baseline to 4 months
baseline to 4 months
Weight for age Z-score < -3 at 4 months
4 months
Freedom from necrotizing enterocolitis (NEC) through 4 months of age
4 months
- +3 more secondary outcomes
Study Arms (2)
Breastfeeding clinical practice guideline (CPG)
EXPERIMENTALThe clinical practice guideline (CPG) intervention will be developed by the clinical centers randomized to this arm. The intervention plan will likely include: 1) prenatal counseling; 2) viewing a video on breastfeeding CHD infants; 3) individual counseling by a registered lactation consultant (RLC), 4) weekly personal contact in-hospital by the RLC, 5) frequent contact post discharge by the RLC through the first year or until breastfeeding is discontinued, 6) provision of high-quality breast pumps, 7) incentive to continue with pumping breastmilk or direct breastfeeding.
Standard of Care
NO INTERVENTIONThis arm will receive standard of care with respect to breastfeeding at the clinical centers randomized to this group.
Interventions
The clinical practice guideline (CPG) intervention will be developed by the clinical centers randomized to this arm. The intervention plan will likely include: 1) prenatal counseling; 2) viewing a video on breastfeeding CHD infants; 3) individual counseling by a registered lactation consultant (RLC), 4) weekly personal contact in-hospital by the RLC, 5) frequent contact post discharge by the RLC through the first year or until breastfeeding is discontinued, 6) provision of high-quality breast pumps, 7) incentive to continue with pumping breastmilk or direct breastfeeding.
Eligibility Criteria
You may qualify if:
- Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
- Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
- Admission to the ICU (either CICU or NICU) at participating center in 1st week of life and for whom cardiac surgical or transcatheter intervention is anticipated in the first 30 days of life.
- Willing to comply with protocol and provide written informed consent
You may not qualify if:
- Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
- Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.
- Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
- Infant birthweight \<3rd percentile for gestational age
- Infant gestational age \< 36 weeks
- Infant with known genetic disorder likely to impact breastfeeding, such as trisomy 21 or cleft palate
- Medical condition or congenital anomaly that precludes safe direct breastfeeding for the infant as determined by investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carelon Researchlead
Study Sites (17)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Golisano Children's at UK
Lexington, Kentucky, 40502, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan Health System, Ann Arbor
Ann Arbor, Michigan, 48109, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Children's Hospital of New York
New York, New York, 10032, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William Mahle, MD
Children's Healthcare of Atlanta
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2026
First Posted
May 13, 2026
Study Start
July 22, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
August 1, 2030
Last Updated
September 10, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be shared as soon as possible, but no later than the time of an associated publication or the end of the grant period, whichever comes first. Data will be available for as long as it is deemed useful for the larger research community, as directed by the PHN NHLBI project officers.
- Access Criteria
- Creation of (free) login on PHN public website
De-identified public use datasets with all study data will be created in accordance with NIH policy